Methods, compositions, and delivery systems for therapeutic skin treatments

ABSTRACT

Disclosed are skincare formulations, delivery systems and treatment methods containing an oligopeptide and a combination of antioxidants for topical application to the skin before and/or after dermatological procedures that affect the skin&#39;s barrier. The systems herein alleviate discomfort and enable rapid healing of irritated and damaged skin, and provide improved treatment outcomes for dermatological procedures. The disclosed topical formulations, delivery systems, and methods thereof provide enhanced penetration of the active ingredients to the skin while maintaining skin moisture and protecting sensitive skin after dermatological procedures for improvement of aesthetic skin properties. Also provided are methods for therapeutic treatment of dermatological conditions by topically applying, using, for example, a pre-moistened bio-cellulose mask, a formulation comprising (% w/w) at least 0.0001% palmitoyl sh-tripeptide-4 amide on an active basis and at least 0.1%  Camellia sinensis  leaf extract.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application Ser. No. 62/810,079, filed Feb. 25, 2019,the entire contents of which are incorporated herein by reference.

FIELD

The present invention relates to the field of therapeutic treatments andcompositions for skincare, including skincare treatments andformulations for application to the skin, for example, in combinationwith any skincare treatment or regimen at-home or professionallyadministered, including before and/or after dermatological proceduresthat affect, for example, disrupt, the skin's barrier to alleviatediscomfort and enable healing of the skin and to improve treatmentoutcomes, as well as to methods for their application to the skin,formulation, manufacture and use thereof.

BACKGROUND

Various dermatological procedures, such as microneedling, RFmicroneedling, laser, chemical peels, intense light therapy,microdermabrasion or dermaplaning, are used to treat and improveconditions like acne scarring, fine lines and wrinkles, loose skin, skintexture, pore size, brown spots, stretch marks, and pigment issues. Suchprocedures tend to disrupt the skin's barrier and/or cause redness,irritation, inflammation, among other skin conditions, which need to beaddressed and corrected. For example, in microneedling procedures themicroneedling depth is enough to draw blood and to irritate and/orinflame the skin, which could require healing.

Other anti-aging and corrective skin procedures can involve chemical,thermal and mechanical wounds. Patients having such treatments haveextremely irritated and sensitive skin after the treatment requiringfurther post-procedure treatments with, for example, cold compresses,wet soaks or occlusive ointments. However, some such post-treatments maycause further irritation and inflammation, rather than alleviate thepost-procedure condition being treated.

Mask sheets are used in skincare and are shaped to be attached to, forexample, the face. Such masks are used for burn treatment, skinmoisturizing, skin whitening or skin nutrition, and are made ofnon-woven fabrics, such as vegetable cellulose fibers, i.e., cotton orpulp, or of synthetic fibers. Some such sheets have been foundproblematic since the sheets dry within a short period of time afterapplication and foreign materials, such as dust, may also get attachedto the skin along with the mask sheets. Bio-cellulose mask sheetssaturated with water also are used for applying to the skin.

The prior methods, formulations, and delivery systems, however, do notprovide efficacious and fast acting pain and swelling relief, orimproved treatment outcomes from the applied dermatological procedures.Typically, such do not prevent discomfort and inflammation, and are noteffective in rapid healing of the skin conditions described above thatoccur, for example, in situations of dermatological procedures affectingthe skin's barrier.

Accordingly, there is a need in the art for improved methods,formulations and delivery systems thereof that can provide treatment tothe skin of those in need thereof to alleviate and ameliorate one ormore of the conditions noted above. More specifically, there is a needin the art for improved skincare formulations and methods to treatredness, irritation, inflammation, among other skin conditions, and toimprove treatment outcomes in dermatological office procedures, byutilizing such formulations and methods either before or afterdermatological procedures, such as microneedling, laser, chemical peels,intense light therapy, microdermabrasion or dermaplaning, that causedisruption, irritation and/or inflammation of the skin, and with otheranti-aging and corrective skin procedures that can involve chemical,thermal and mechanical irritation and wounds to the skin.

The methods and systems disclosed herein are designed to provide coolingand soothing features to sooth, calm, reduce redness, swelling andburning sensations, and prevent inflammation and promote healing moreeffectively than prior topical formulations and systems.

SUMMARY

The present disclosure provides skincare treatments, formulations, anddelivery systems thereof, and more particularly, therapeutic treatmentsand delivery systems with formulations having a therapeuticallyeffective amount of an oligopeptide and one or more antioxidants.

In certain embodiments, the oligopeptide is at least 0.001% w/w on anactive basis. In other embodiments, the one or more antioxidant is atleast 0.1% w/w. The disclosed embodiments, treat redness, swelling,burning, and other such dermatological conditions.

Aspects of the present disclosure provide methods for therapeutictreatment of skin in dermatological procedures by topically applying toskin, selected for a dermatological procedure, a therapeuticallyeffective amount of a formulation comprising an oligopeptide and one ormore antioxidants, wherein the oligopeptide is at least 0.0001% w/w onan active basis and the one or more antioxidant is at least 0.1% w/w. Incertain embodiments, the dermatological procedure affects the skin'sbarrier. The dermatological procedures may include microneedling, RFmicroneedling, laser, chemical peels, intense light therapy,microdermabrasion, dermaplaning.

In aspects of the present disclosure, the methods include applying amicroneedling procedure to the skin, topically applying the formulationbefore the microneedling procedure, and topically applying theformulation after the microneedling procedure.

The formulation is effective in one or more of healing, reducingsymptoms associated with dermatological procedures, soothing the skin,enhancing treatment outcome. The methods disclosed herein may includeapplying a biocellulose mask to the skin selected for a dermatologicalprocedure, wherein the biocellulose mask is pre-moistened with theformulation.

In further aspects of the present disclosure, the oligopeptide ispalmitoyl sh-tripeptide-4 amide. In yet further aspects of the presentdisclosure, the antioxidant is one or more of Camellia sinensis leafextract, resveratrol, ectoin, Cucumis satvius fruit extract,ergothioneine, Phyllanthus emblica fruit extract.

In aspects disclosed herein, the skin may be very dry human skin. In yetfurther aspects, the formulation may include one or more of purifiedwater, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camelliasinensis leaf extract, resveratrol, palmitoyl sh-tripeptide-4 amide,ectoin, bisabolol, Cucumis satvius fruit extract, ergothioneine,Phyllanthus emblica fruit extract, caffeine. In yet further aspects ofthe present disclosure, the formulation is sterile.

The present disclosure contemplates the dermatological procedure is anat-home skin practice or regimen. The present disclosure furthercontemplates, the dermatological procedure is a cosmetic procedureperformed by a physician, esthetician, skincare practitioner, or homeuser.

Aspects of the present disclosure include a topical formulation fortherapeutic treatment of skin in dermatological procedures, comprisingan oligopeptide and one or more antioxidants, wherein the oligopeptideis at least 0.0001% w/w on an active basis and the one or moreantioxidant is at least 0.1% w/w.

In aspects herein, the formulation includes (% w/w) 10%-99% purifiedwater; 0.001%-75% hydrolyzed sodium hyaluronate; 0.001%-10% sodiumhyaluronate; 0.001%-99% Camellia sinensis leaf extract; 0.001%-5.0%resveratrol; 0.0001%-1% palmitoyl sh-tripeptide-4 amide; 0.001%-5%ectoin; 0.001%-5% ergothioneine; 0.001%-5% bisabolol; 0.001%-99% Cucumissatvius fruit extract; 0.001%-99% sodium pyrrolidone carboxylic acid(PCA); 0.001%-99% Chamomila recutita flower extract; 0.001%-99% comfreyextract (e.g., ABS comfrey extract paraben free (PF)); 0.001%-99% yuccaglauca root extract; 0.001%-5% Phyllanthus emblica fruit extract;0.001%-5% caffeine; 0%-2% sodium phosphate; 0%-0.5% potassium hydroxide;0.0%-3.5% phenylcarbinol; 0.0%-0.5% sodium benzoate; 0.0%-0.3% disodiumEthylenediaminetetraacetic acid (EDTA); 0.01%-10% polysorbate 20.

In yet further aspects of the present disclosure, the formulationincludes (% w/w) 82.41% purified water; 1.00% hydrolyzed sodiumhyaluronate; 0.10% sodium hyaluronate; 0.01% Camellia sinensis leafextract; 0.01% resveratrol; 4.00% palmitoyl sh-tripeptide-4 amide; 0.01%ectoin; 0.01% ergothioneine; 0.20% bisabolol; 0.01% Cucumis satviusfruit extract; 0.01% sodium PCA; 0.01% Chamomila recutita flowerextract; 0.01% ABS comfrey extract PF (Symphytum officinale leafextract, Leuconostoc/radish root ferment filtrate); 0.01% yucca glaucaroot extract; 0.10% Phyllanthus emblica fruit extract; 0.01% caffeine;0.638% sodium phosphate; 0.226% potassium hydroxide; 0.20%phenylcarbinol; 0.05% sodium benzoate; 0.05% disodium EDTA; 0.70%polysorbate 20.

Aspects of the present disclosure provide a sheet for therapeutictreatment of skin in dermatological procedures, comprising the sheetstructured for topical application to skin selected for a dermatologicalprocedure, the sheet being pre-moistened with a therapeuticallyeffective amount of a formulation comprising an oligopeptide and one ormore antioxidants, wherein the oligopeptide is at least 0.0001% w/w onan active basis and the one or more antioxidant is at least 0.1% w/w. Inaspects herein, the sheet may be a biocellulose sheet structured as afacial mask. In yet other aspects of the present disclosure, theformulation and/or sheet pre-moistened with the formulation issterilized.

The compositions and delivery systems exhibit low irritancy, andimproved, synergistic efficiency of the formulated ingredients,including improved alleviation of discomfort and healing in the subject.In particular, the present disclosure provides cosmetic treatments anddelivery systems with formulations having a combination of components,which exhibit lower irritancy, better regression time, and improvedpenetration properties of all the formulated active ingredients into theskin as compared with other skincare products.

The present disclosure contemplates use of the disclosed formulations aspre-treatment and/or post-treatment agents for skincare treatments. Asdiscussed in further detail below, the formulations of the presentdisclosure have enhanced discomfort relief and provide enhanced healingof the skin in conditions arising from certain dermatologicalprocedures.

More specifically, the present disclosure contemplates use of themethods of treatment and formulations herein both in pre-treatment andpost-treatment modes. In pre-treatment, the skin is conditioned, coolingand hydrating it as well as transdermally delivering or topicallyproviding antioxidants, peptides, humectants, and soothing botanicals,preventing or reducing negative effects of the procedure, skincareregimen or other skin disruptive or other barrier disruptive aggressors,such as sun exposure, dry climate, intrinsic and extrinsic skin dryness,redness, irritation, swelling, and wounds.

In post-treatment, the methods of treatment and formulations herein workto prevent and decrease both immediate and late onset of undesirableeffects, such as redness, swelling, edema, itching, burning, wounds ofthe skin, bleeding, sensitive skin, skin damage, post-procedurehyperpigmentation, scabbing, and weeping wounds. As a result, themethods of treatment and formulations herein also improve treatmentoutcomes and aid in patient compliance with their post-procedure care.The methods of treatment and formulations herein also make it possibleto have the procedures, when administered as a series over time,repeated at closer intervals due to faster recovery. Aside fromalleviating discomfort and raw or challenged skin appearancepost-procedure, use of the methods of treatment and formulations hereinallow the user to return to normal activities faster, and with lessdiscomfort or side effects.

Topical application of the disclosed formulations may includeapplication to specific body areas, such as, without limitation, feet,elbows, knees, that are susceptible to dermatological conditions of thetype requiring the therapeutic treatments disclosed herein. Suchtreatments may be applied, for example, 1-3 times per day, for example,after showering, among others. The present disclosure contemplates thatthe disclosed treatments would reduce the dermatological conditions ofthe affected areas, followed by regular topical applications, asdesirable or necessary, to maintain the improved condition of the bodyareas under treatment.

In some embodiments, the present disclosure provides formulationscomprising sodium hyaluronate, such as hydrolyzed sodium hyaluronate.The present disclosure contemplates other combinations of the activeingredients disclosed herein such that the desired improved treatmentresults are achieved. Surprisingly, it has been found that thecombination of a peptide, such as, palmitoyl sh-tripeptide amide, andantioxidants, such as Camellia sinensis leaf extract, or hydrolyzedsodium hyaluronate or green tea polyphenols or ectoin or ergothioneineor emblica or bisabolol or resveratrol or other antioxidants, eitheralone, but advantageously in combination, and most advantageously in thecombinations listed herein, yields surprising and unexpected results forhealing and irritation relief in skincare procedures.

The disclosed treatments comprise one or more peptides, antioxidants,sodium hyaluronate, including hydrolyzed sodium hyaluronate.

The disclosed compositions may also comprise one or more moisturizersand/or humectants. In one aspect of this embodiment, the moisturizerand/or humectant is sodium hyaluronate, such as fractionated andlong-chain sodium hyaluronate, from single monomer to about 5 millionDaltons, to bind moisture to the skin and penetrate the skin carryingmoisture.

The disclosed formulations may also comprise skin soothing agents, suchas antioxidants, to reduce skin inflammation and irritation.

The disclosed treatments may also comprise one or more soothingantioxidants to calm the skin and reduce inflammation. In one aspect ofthis embodiment, the antioxidant is a polyphenol. In a more specificaspect of this embodiment, the antioxidant comprises a polyphenolisolate, or a mixture of polyphenol isolates, of Camellia sinensis.

In certain embodiments, the disclosed treatments may be provided using asheet-like structure, such as a face mask configured for attachment toan area selected for a dermatological procedure. The present inventorshave found biocellulose face masks surprisingly effective in providingthe therapeutic treatments with the disclosed formulations, as discussedin further detail hereinafter.

DETAILED DESCRIPTION

The present disclosure provides skincare formulations, delivery systems,and methods of use thereof for alleviation or amelioration ofdermatological conditions relating to dermatological procedures thatirritate and/or wound human skin. Dermatological conditions amenable totreatments disclosed herein include, without limitation, inflammatorydisorders of the skin and skin conditions characterized by increasedcell turnover including psoriasis, photoaging, weather-beatenappearance, yellowing, loss of elasticity, loss of collagen richappearance and/or youthfulness, redness, dryness, age spots, skinwrinkles, acne, rosacea, ichthyosis. The disclosed therapeuticformulations are also useful for improvement in one or more aestheticcriteria, including, but not limited to, a perceived improvement inapparent skin age, skin tone, weather-beaten appearance, yellowing, lossof elasticity, redness, dryness, age spots, skin wrinkles, skinsmoothness, brightness, radiance, as well as skin pores becoming lessnoticeable.

As used herein, the terms “treatment” or “treating” with respect to askin condition generally mean “having positive effect on a skincondition” and encompass reduction, amelioration, and/or alleviation ofat least one symptom of a skin condition, a reduction, amelioration,and/or alleviation in the severity of the skin conditions, or delay,prevention, or inhibition of the progression of the skin condition.Treatment, as used herein, therefore does not require total curing ofthe condition. A formulation of the present disclosure that is usefulfor treatment of a skin condition, or a method of treating a skincondition, need only reduce the severity of a skin condition, reduce theseverity of symptoms associated therewith, provide improvement to apatient's quality of life, or delay, prevent, or inhibit the onset ofone or more symptoms of a skin condition. As used herein, these termsalso encompass aesthetic improvements to the skin upon application ofthe disclosed formulations having a combination of, for example, anoligopeptide, antioxidants, and hyaluronic acid or its derivatives.

As used herein, the terms “application,” “apply,” and “applying” withrespect to a disclosed topical formulation or method of using adisclosed topical formulation, refer to any manner of administering atopical formulation to the skin of a patient which, in medical orcosmetology practice, delivers the formulation to the patient's skinsurface. Smearing, rubbing, spreading, spraying a disclosed topicalformulation, with or without the aid of suitable devices, on a patient'sskin are all included within the scope of the term “application,” asused herein. The term “topical” or “topically” with respect toadministration or application of a disclosed skincare formulation refersto epicutaneous administration or application, onto skin.

The present disclosure further contemplates administration orapplication of the disclosed skincare formulations using a sheet-likestructure, such as a mask configured for attachment to a desired area.In particular, the present disclosure contemplates use of applicatorsystems, such as biocellulose face masks, which are surprisinglyeffective in providing therapeutic treatments with the disclosedformulations.

A biocellulose mask is a device, generally supplied as a sheet, eitherindividual or multiple quantities per package, which may be pre-cut toconform more easily to a particular body area or, for example, containcut-out areas for eyes, nose, mouth, or perhaps have cuts or wedgesremoved in order to facilitate better adhesion to the skin when wet withwater or a treatment solution.

The present disclosure contemplates any suitable biocellulose materialfor the types of masks disclosed herein. In this, a person skilled inthe art would be familiar with such materials and masks thereof.Biocellulose fibers are hydrophilic and hold water and hydrophilicsolutions very efficiently. They conform well to the skin providing anefficient diffusion gradient, with beneficial ingredients entering theskin and having the potential to absorb unwanted allergens or chemicalsfrom the skin. The moisture trapping ability allows the mask toevaporate water at a high rate, causing continued cooling over longperiods of time, even when applied to warm skin. This provides coolingcomfort and reduction of redness, swelling and other complications afterlaser or other treatments which may disrupt the skin's barrier, viaphysical, thermal, chemical or other types of wounding. Further, thisprovides effective treatment and healing of such types of skin barrierwounding.

Biocellulose fibers and sheet goods may be easily sterilized by heat,chemical, radiation, or other methods. They are largely inert and do notirritate or exacerbate skin injury during treatment. They transmitactive ingredients efficiently and hold them in stable formulation overa reasonable shelf life.

The present disclosure further contemplates the use of masks of anysubstrate material that is suitable for the purposes and resultsdiscussed herein.

As used herein, the phrase “effective amount” refers to an amount of aformulation of the present disclosure, or component thereof, effectiveto treat a skin condition as noted above, including a range of effects,from a detectable local improvement in an area of topical application tosubstantial relief of symptoms to an improvement in one or moreaesthetic criteria, including, but not limited to, a perceivedimprovement in apparent skin dryness, keratosis pilaris, age, radiationdamage, sun or uv damage, skin tone, weather-beaten appearance,yellowing, loss of elasticity, redness, dryness, age spots, skinwrinkles, skin smoothness, brightness, radiance, as well as skin poresbecoming less noticeable. The effective amount will vary with theparticular condition or conditions being treated, the severity of thecondition, the duration of the treatment, the specific components of thecomposition being used, and other factors. More specifically, thedisclosed compositions and formulations provide a method for therapeutictreatment of skin by providing, in some embodiments, a combination of anoligopeptide and an antioxidant, in an efficacious manner to the skin.

The disclosed compositions, formulations and methods of use thereofreduce, minimize, or eliminate normally-observed dry skin conditionsincluding, inter alia, conditions characterized by redness, swelling,itching, severe skin flaking, breakdown of the skin barrier, discomfort,extreme dryness, cracking of the skin, burning sensation andsensitization. The disclosed compositions, formulations, and methods ofuse thereof also provide aesthetic improvements in the skin, including,but not limited to, skin that appears younger, skin exhibiting a moreeven tone, skin in which the pores are less noticeable, and skin that isjudged by the user to be smoother, and/or to be improved with respect toits weather-beaten or aged appearance, yellowing, loss of elasticity,redness, dryness, age spots, and/or skin wrinkles and scarring, forexample, acne scarring and other pitted lesions and melasma or otherskin pigmentation issues immediately after medical or aestheticprocedures to the skin and for a length of time thereafter where thesubject may feel discomfort or dryness of any kind.

As used herein, the phrase “skin barrier” refers to the outermost layerof the skin's surface. As is generally known, the skin barrier has cellsand lipids, and may also be referred to as the permeability barrier,moisture barrier, or lipid barrier. The skin barrier preventsevaporation of essential water and electrolytes from the skin, amongother functions. As disclosed herein, various processes may disrupt,i.e., weaken or affect, the skin barrier causing, among others, pain,swelling, redness, dryness, irritation, susceptibility to infection,which require healing and repair. The extent of skin barrier disruptionmay vary based on the specific dermatological procedure from minorpenetration to depths that draw blood to the skin surface. For example,microneedling procedures may be adjusted for depths of penetration basedon the skin conditions under treatment. Various dermatologicalprocedures are used for promoting collagen production to treat skinconditions.

As used herein, the phrase “dermatological procedure” refers tosurgical, medical, or simple procedures, for example, rendered by aphysician, esthetician, skincare service provider, or end-user at home.For example, at home daily, simple cleansing and moisturizing routines,such as treating a person's simple dry skin condition, affecting theskin barrier, are within the scope of the phrase “dermatologicalprocedure.”

As used herein, the terms “masks” or “mask sheets” refer to shaped orunshaped sheet-like structures that are used in skincare and may beshaped to be attached to, for example, the face. Such sheets are usedfor burn treatment, skin moisturizing, skin whitening or skin nutrition,and are made of non-woven fabrics, such as vegetable cellulose fibers,i.e., cotton or pulp, or of synthetic fibers. In certain embodimentsherein, biocellulose sheets saturated with formulations disclosed hereinmay be used for effectively delivering active agents to the skin and forprotecting and soothing the skin barrier.

As used herein, the term “on an active basis” refers to the actualpercentage or composition of an active ingredient, such as a peptide, asused in a formulation.

Sheets may be used, for example, for facial masks, adhesive skinpatches, or the like, used for facial treatment, skin treatment, or thelike, including delivery systems, i.e., carriers, of active ingredientssuch as skin healing/repair components, and the like. These sheets areadhered to the skin to impart active components contained in the sheetsto the skin surface. In addition, when a sheet contains various activeingredients and is tightly adhered to the skin, the sheet providesfunctions, such as controlling skin temperature, water retention and/orsupplying the active ingredients in the sheet to the skin. Inparticular, when a sheet having a liquid component is adhered to theskin and kept in place for some time, physiology of the skin can beimproved owing to, for example, favorable moisture content ortemperature. Such functionality of the systems disclosed herein havesurprisingly been found to improve penetration of active agents into theskin thereby enabling rapid healing and relief from irritation andredness.

In addition to the foregoing, the present disclosure contemplates use ofadditional methods of applying the disclosed formulations including, butnot limited to, spray aerosol, cotton pads and balls, gauze, foam,tissue applicators, human hands, among others.

The skincare compositions and delivery systems disclosed herein not onlymaintain the active properties of the active agents, but also providegreater efficiency of the active agents. In one aspect of thisdisclosure the skin is human skin. In other aspects of the presentdisclosure, the skin is that of a companion animal, a domestic animal,or a commercially useful animal.

The present inventors have found that the treatments of the presentdisclosure are effective therapeutically for treating dermatologicalconditions. In certain embodiments of the present disclosure, skincareformulations are provided having 0.01% of palmitoyl sh-tripeptide 4amide, 0.2% of an antioxidant, 1% of sodium hyaluronate, such ashydrolyzed sodium hyaluronate.

In certain embodiments, the disclosed compositions may also comprise oneor more moisturizers and/or humectants.

Humectants are hygroscopic substances used to keep things moist, often amolecule with several hydrophilic groups, or capable of hydrogen bondingwith water, or having other polar organic functional groups. Humectantscan also function as solvents or cosolvents.

Some examples of humectants include, but are not limited to, aminoacids; glycols and polyols, such as propylene glycol, hexylene glycol,and butylene glycol, including polymeric and sugar-basedpolyols/alcohols, for example, glycerol, sorbitol, xylitol, maltitol,polydextrose; mucopolysaccharides and carbohydrates, for example, aloevera gel, yucca extract, dextrose and polydextrose; alpha hydroxy acidssuch as glycolic acid, lactic acid; albumen; esters or amides of aceticacid or similar; soluble carbohydrates, such as sugar, honey; salts,such as potassium chloride, sodium PCA, salts of polycarboxylic acids;amides, such as urea and urea derivatives.

In one aspect of these embodiments, the moisturizer and/or humectant issodium hyaluronate, such as fractionated and long-chain sodiumhyaluronate, from single monomer to about 5 million Daltons, to bindmoisture to the skin and penetrate the skin carrying moisture.Hyaluronate is a moisture binder that helps keep the skin hydrated andprovides “slip” (sensory aesthetics) to the disclosed formulations.

The disclosed formulations also comprise one or more solubilizingagents, rheology modifiers and/or emulsifiers. In one aspect of thisembodiment, the solubilizing agent/emulsifier is a non-ionicsolubilizing agent/emulsifier. In one specific aspect of thisembodiment, the solubilizing agent/emulsifier is polysorbate 20.

In other aspects of these embodiments, the emulsifier may be one or moreof PEG-100 stearate. cetearyl alcohol, cetearyl glucoside, polysorbate60, stearyl alcohol, glyceryl stearate, sodium polyacrylate, emulsifyingwax.

In further aspects of the disclosed formulations, xanthan gum, such asKeltrol T®, may be provided as an emulsifier for a stable emulsion.

In yet further aspects of the disclosed formulations, an artificialthickening agent, such as Rapithix A-60® from Ashland Chemical, may beprovided.

The disclosed treatments may also comprise one or more soothingantioxidants to calm the skin and reduce inflammation.

Antioxidants inhibit oxidation, a type of chemical reaction that mayproduce free radicals. Antioxidants may assist in modulatinginflammation, preventing or diminishing allergic or irritant reactionsin the skin, including over-stimulation of histamine up-regulation.

In this, in the presently disclosed formulations and treatmentsantioxidants assist in reducing the sting and irritation normallyassociated with application of high levels of active ingredients, aswell as calming the existing condition for which the skin is beingtreated. This brings relief to the user, which leads to heightenedcompliance with the subject's treatment protocols.

Exemplary antioxidants include, but are not limited to, polyphenols,ergothioneine, glutathione, tetrahexyldecyl ascorbate, ascorbatederivatives, tocopherols or derivatives thereof, herbals such aspomegranate, cranberry, quercetin, carotenoids, resveratrol, ferulicacid, caffeic acid, gallic acid, topical compounds preventing orreducing the number of oxidative events in the skin, whether or notinduced by uv light or solar exposure.

In one aspect of this embodiment, the antioxidant is a polyphenol. In amore specific aspect of this embodiment, the antioxidant comprises apolyphenol isolate of Camellia sinensis. The antioxidant can be apolyphenol or a mixture thereof that is isolated from plants, chemicallysynthesized; the antioxidant can also be a semi-synthetic compoundprepared by modification of a natural polyphenol or mixture ofpolyphenols. In specific embodiments of the present disclosure, theantioxidant includes “green tea polyphenols” isolated and purified fromthe leaves of Camellia sinensis plants. These antioxidants, asformulated and delivered herein, provide antioxidant activity as well asanti-inflammatory activity, and, further, provide skin soothing,protection, and repair activity.

Other antioxidants contemplated by the present disclosure include, butare not limited to, vitamin E acetate.

The disclosed treatments may also comprise one or more emollients.Emollients soften, lubricate and protect the skin from trans-epidermalwater loss (TEWL). Some examples of emollients include, but are notlimited to, lipids, phospholipids, occlusives, petrolatum, waxes,paraffinic oils, vegetable and animal fats, esters, such as isopropylmyristate, dicaprylyl carbonate, isopropyl palmitate, ethoxylates orpropoxylates esters and fats, silicones, butters (cocoa butter, sheabutter, etc.) and polyethylene glycols (PEG).

Skin lipids are the “mortar” in the brick and mortar model of the skin.These fats, oils and waxes may have more or less hydrophilic tendencyand help prevent trans-epidermal water loss (TEWL), and allow the skinto retain moisture and more effectively repair itself. Examples areceramides, phospholipids, phytosphingosine, cholesterol, lanosterol,fatty acids, sebum components, many of which can exist and be functionalin its natural form, or be functional in the presently disclosedcompositions and treatments as a derivative or synthetic analog.

In one aspect of this embodiment, the emollient is an ester or oil. Invarious aspects of this embodiment, the emollient can include, withoutlimitation, one or more of the following shea butter, cocoa butter,mineral oil, lanolin, petrolatum, paraffin, beeswax, squalene, squalane,cetyl alcohol, olive oil, triethylhexanoin, coconut oil, jojoba oil,sesame oil, almond oil, or other plant oils, lipids, and combinations oftwo or more thereof.

Other emollients contemplated by the present disclosure include, but arenot limited to, caprylic/capric triglyceride.

The disclosed formulations may also comprise other skin soothing agents,such as antioxidants, to reduce skin inflammation and irritation, andbio-mimetic ceramide complex that mimics the skin's natural lipidprofile.

In certain embodiments of the presently disclosed formulations,ingredients therein include amino acid mixtures having one or more aminoacids. In specific aspects of these embodiments, the amino acid mixtureshave a profile of the human skin's natural moisturizing factor (NMF).

In other embodiments of the present disclosure, the skin treatmentformulations include an amino acid mixture, having a profile of thehuman skin's natural moisturizing factor (NMF), including the followingcomponents formulated within the indicated ranges (all expressed as %w/w): Purified water (QS to 100%), disodium EDTA (0.10%), glycine(1.612%), L-citrulline (1.00%), L-alanine (0.921%), L-proline (0.148%),L-ornithine monohydrochloride (0.287%), Larginine (0.073%), L-glutamicacid (0.243%), L-histidine (0.429%), valine (0.381%), L-lysine (0.179%),L-aspartic Acid (0.30%), leucine (0.262%), threonine (0.713%), tyrosine(0.295%), DL-phenylalanine (0.283%), taurine (0.032%), L-isoleucine(0.194%), methionine (0.072%), serine (2.32%).

In certain embodiments of the present disclosure, the formulations mayinclude one or more solubilizing/emulsifying, skin-conditioning/treatingagents and preservatives/stabilizing agents, such as butylene glycol,caprylic/capric triglyceride, phospholipids, SK-Influx V®, glycerin,lecithin, tocopheryl acetate, ubiquinone (co-enzyme Q10), hydrolyzedglycosaminoglycans, hexanoyl dipeptide-3 norleucine acetate, salix nigra(willow) bark extract, mandelic acid, bisabolol, ceramide NP, ceramideAP, phytosphingosine, cholesterol, ceramides EOP, glycine, citrulline,alanine, proline, ornithine HCl, arginine, glutamic acid, histidine,valine, lysine, aspartic acid, leucine, threonine, tyrosine,phenylalanine, taurine, isoleucine, methionine, serine, sodium lauroyllactylate, hydrogenated polydecene, trideceth-6, xanthan gum, carbomer,sodium benzoate, phenoxyethanol, disodium EDTA.

In one embodiment of the present disclosure, the skin treatmentformulations include the following ingredients: purified water,hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensisleaf extract, resveratrol, palmitoyl sh-tripeptide-4 amide, ectoin,ergothioneine, bisabolol, Cucumis satvius (cucumber) fruit extract,sodium PCA, Chamomila recutita (matricaria) flower extract, ABS comfreyextract PF (Symphytum officinale leaf extract, Leuconostoc/radish rootferment filtrate), yucca glauca root extract, Phyllanthus emblica fruitextract, caffeine, sodium phosphate, potassium hydroxide,phenylcarbinol, sodium benzoate, disodium EDTA, polysorbate 20.

In other embodiments of the present disclosure, the skin treatmentformulations include the following components formulated within theindicated ranges (all expressed as % w/w): water (10%-99%), hydrolyzedsodium hyaluronate (0.001%-75%), sodium hyaluronate (0.001%-10.0%),Camellia sinensis leaf extract (0.001%-99%), resveratrol (0.001%-5.0%),palmitoyl sh-tripeptide-4 amide (0.0001%-4.0% on an active basis),ectoin (0.001%-5.0%), ergothioneine (0.001%-5.0%), bisabolol(0.001%-10%), Cucumis satvius (cucumber) fruit extract (0.001%-99%),sodium PCA (0.001%-99%), Chamomila recutita (matricaria) flower extract(0.001%-99%), ABS comfrey extract PF (Symphytum officinale) leaf extract(0.001%-99%), Leuconostoc/radish root ferment filtrate (0.0%-5%), yuccaglauca root extract (0.001%-99%), Phyllanthus emblica fruit extract(0.001%-5.0% on an active basis), caffeine (0.001%-5.0%), sodiumphosphate (0.0%-2.0%), potassium hydroxide (0.0%-0.5%), phenylcarbinol(0.0%-3.5%), sodium benzoate (0.0%-0.5%), disodium EDTA (0.0%-0.3%),polysorbate 20 (0.0%-10.0%).

In certain embodiments of the present disclosure, the formulationincludes the following ingredients formulated within the indicatedranges (all expressed as % w/w): purified water (82.41%), hydrolyzedsodium hyaluronate (1.00%), sodium hyaluronate (0.10%), Camelliasinensis leaf extract (0.01%), resveratrol (0.01%), palmitoylsh-tripeptide-4 amide (4.00%), ectoin (0.01%), ergothioneine (0.01%),bisabolol (0.20%), Cucumis Satvius (cucumber) fruit extract (0.01%),sodium PCA (0.01%), Chamomila recutita (matricaria) flower extract(0.01%), ABS comfrey extract PF (Symphytum officinale) leaf extract,Leuconostoc/radish root ferment filtrate (0.01%), yucca glauca rootextract (0.01%), Phyllanthus emblica fruit extract (0.10%), caffeine(0.01%), sodium phosphate (0.638%), potassium hydroxide (0.226%),phenylcarbinol (0.20%), sodium benzoate (0.05%), disodium EDTA (0.05%),polysorbate 20 (0.70%).

Topical application of the disclosed formulations may includeapplication to specific body areas, such as, without limitation, feet,elbows, knees, that are susceptible to dermatological conditions of thetype requiring the therapeutic treatments disclosed herein. Suchtreatments may be applied, for example, 1-3 times per day, for example,before and/after invasive dermatological procedures of affected areas,followed by regular topical applications, as desirable or necessary, tomaintain the improved condition of the body areas under treatment. Incertain embodiments, the actual dosage of the formulations of thepresent disclosure to be topically applied to the skin will depend on,inter alia, the condition to be treated, the particular regimen to befollowed, and the persona preferences of the user.

The present disclosure contemplates the use of masks or mask sheets,shaped or unshaped, as delivery systems in the skincare treatmentsdisclosed herein. Such masks may be shaped to be attached to, forexample, the face and may be made of non-woven fabrics, such asvegetable cellulose fibers, i.e., cotton or pulp, or of syntheticfibers.

In certain embodiments disclosed herein, biocellulose sheetspre-moistened, i.e., saturated, with formulations disclosed herein maybe used for applying to the skin. The present disclosure providesbiocellulose face masks that are manufactured using biocellulose sheets.The sheets are shaped to, for example, facial contours. The formed masksare then impregnated, i.e., moistened, with the skincare formulationsdisclosed herein. The pre-moistened masks are then packed in, forexample, foil pouches and irradiated for sterilization. Laboratorytesting is conducted to ensure mask quality standards.

Formulations of the present disclosure may be prepared under ambientconditions. In certain embodiments, formulations of the presentdisclosure are prepared under an inert atmosphere. In particular aspectof this embodiment, the inert atmosphere is an inert gas, such as butnot limited to, nitrogen, argon, or combinations thereof. In certainembodiments formulations of the present disclosure are prepared under adry inert atmosphere, which may comprise, consist essentially of, orconsist of one or more dry inert gases, including but not limited to drynitrogen, dry argon, or a combination thereof.

EXAMPLE

Dermatologic procedures may be accompanied by slow healing andpost-treatment discomfort. Biocellulose masks according to the presentdisclosure are designed to, for example, relieve post-procedurediscomfort, improve rates of healing, and reduce the appearance ofredness, among other beneficial results disclosed herein.

The following study was carried out to evaluate the efficacy and safetyof a sterile, treatment-formulation infused, biocellulose mask accordingto the present disclosure to accelerate healing, enhance improvement,and reduce post-procedure discomfort following a RF/microneedlingtreatment of the face.

Ten healthy females aged 35 to 60 years, moderate wrinkles, enrolled inthe open-label, single-site pilot study. Subjects were treated once with2 passes of a microneedle radio-frequency (RF) device. Treatment wasimmediately followed by application of a biocellulose mask according tothe present disclosure to the entire face for 15 to 20 minutes. Subjectswere given an additional six masks for daily home use and asked toreturn to the office 3 and 7 days later for evaluation of efficacy andsafety. Skin responses were tracked by photography of subjects' facesimmediately post-procedure (pre- and post-mask application), and on days3 and 7. Clinical grading was performed.

Subjects achieved statistically significant improvement in skinradiance, smoothness, texture, and dryness after a singleRF/microneedling treatment followed by daily usage of the biocellulosemask for 1 week. Skin tone evenness, red/blotchiness, and overallappearance were trending toward significant improvement by Day 7.Adverse events were not observed in any subject.

The results demonstrate the effectiveness of the disclosed biocellulosemasks pre-moistened with the disclosed formulations in soothing skin andaccelerating its healing post a RF/microneedling procedure. The masksand formulations according to the present disclosure may be useddirectly on compromised skin immediately post-microneedling, without anyadverse events. Improvement and conditioning of the facial skin usingthe disclosed masks daily for one week after treatment has been shown.

Exemplary Composition Ranges Ingredient %(w/w) %(w/w) Purified Water QSto 100% 82.41% Disodium EDTA 0.02 0.05% Caffeine 1.00 0.01% SodiumBenzoate 0.1 0.05% Hydrolyzed Sodium Hyaluronate 2.0 1.00% SodiumHyaluronate 0.5 0.10% Cucumis Sativus (Cucumber) Fruit Extract 10.00.01% Camellia Sinensis Leaf Extract 10.0 0.01% Ecto in 0.2 0.01%Ergothioneine 0.1 0.01% Yucca Glauca Root Extract 10.0 0.01% Sodium PCA5.0 0.01% Chamomilla Recutita (Matricaria) Flower 5.0 0.01% Extract ABSComfrey Extract PF: 2.0 Symphytum Officinale Leaf Extract, 0.05 0.01%Leuconostoc/Radish Root Ferment Filtrate Phyllanthus Emblica FruitExtract 0.25 0.10% Purified Water 0.9 10.00% Polysorbate 20 2.2 0.70%Phenylcarbinol 0.95 0.20% Bisabolol 1.5 0.20% Resveratrol 0.75 0.01%Palmitoyl sh-Tripeptide Amide solution 10.0% 4.00% Sodium Phosphate 0.550.638% Potassium Hydroxide 0.20 0.226% Purified Water 1.0 0.226%

What is claimed is:
 1. A topical formulation for therapeutic treatmentof skin in dermatological procedures, comprising (% w/w) 0.001%-10%sodium hyaluronate, an oligopeptide, wherein the oligopeptide is0.0001%-10% palmitoyl sh-tripeptide-4 amide on an active basis, one ormore antioxidants, wherein the one or more antioxidants is between0.1%-10% w/w and comprises one or more of Camellia sinensis leafextract, resveratrol, ectoin, Cucumis satvius fruit extract,ergothioneine, Phyllanthus emblica fruit extract, 10%-99% purifiedwater; 0.001%-75% hydrolyzed sodium hyaluronate; 0.001%-99% Camelliasinensis leaf extract; 0.001%-5.0% resveratrol; 0.001%-5% ectoin;0.001%-5% ergothioneine; 0.001%-5% bisabolol; 0.001%-99% Cucumis satviusfruit extract; 0.001%-99% sodium pyrrolidone carboxylic acid (PCA);0.001%-99% Chamomila recutita flower extract; 0.001%-99% comfreyextract; 0.001%-99% yucca glauca root extract; 0.001%-5% Phyllanthusemblica fruit extract; 0.001%-5% caffeine; 0%-2% sodium phosphate;0%-0.5% potassium hydroxide; 0.0%-3.5% phenylcarbinol; 0.0%-0.5% sodiumbenzoate; 0.0%-0.3% disodium Ethylenediaminetetraacetic acid (EDTA); and0.01%-10% polysorbate
 20. 2. The formulation of claim 1, comprising (%w/w): 82.41% purified water; 1.00% hydrolyzed sodium hyaluronate; 0.10%sodium hyaluronate; 0.01% Camellia sinensis leaf extract; 0.01%resveratrol; 4.00% palmitoyl sh-tripeptide-4 amide; 0.01% ectoin; 0.01%ergothioneine; 0.20% bisabolol; 0.01% Cucumis satvius fruit extract;0.01% sodium pyrrolidone carboxylic acid (PCA); 0.01% Chamomila recutitaflower extract; 0.01% comfrey extract (Symphytum officinale leafextract, Leuconostoc/radish root ferment filtrate); 0.01% yucca glaucaroot extract; 0.10% Phyllanthus emblica fruit extract; 0.01% caffeine;0.638% sodium phosphate; 0.226% potassium hydroxide; 0.20%phenylcarbinol; 0.05% sodium benzoate; 0.05% disodiumEthylenediaminetetraacetic acid (EDTA); and 0.70% polysorbate
 20. 3. Asheet for therapeutic treatment of skin in dermatological procedures,comprising the sheet structured for topical application to skin selectedfor a dermatological procedure, the sheet being pre-moistened with atherapeutically effective amount of a formulation of claim
 1. 4. Thesheet of claim 3, wherein the sheet is a biocellulose sheet and isstructured as a facial mask.
 5. The sheet of claim 3, wherein theformulation and/or sheet pre-moistened with the formulation issterilized.
 6. The topical formulation of claim 1, wherein theformulation is sterile.
 7. The topical formulation of claim 1, whereinthe formulation is a sheet.